Drug firm Alembic Pharmaceuticals Friday said it has received approval from the US health regulator for Acetazolamide extended-release capsules, used for treatment of various kinds of glaucoma.
The approved product is therapeutically equivalent to the reference listed drug Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products R&D Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Acetazolamide extended-release capsules, 500 mg," Alembic Pharmaceuticals said in a BSE filing.
Quoting IQVIA sales data, the company said, Acetazolamide extended-release capsules, 500 mg has an estimated market size of USD 13.1 million for 12 months ending December 2018.
Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
The company said it now has a total of 87 ANDA approvals from the USFDA.
Shares of Alembic Pharmaceuticals were trading 0.63 per cent higher at Rs 542 apiece on the BSE.
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